Orelabrutinib and Obinutuzumab for Treating Marginal Zone Lymphoma

Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma: A Phase 2, Single-Arm, Prospective, Multicenter Clinical Study

This study is testing a new treatment combining Orelabrutinib and Obinutuzumab for people with previously untreated Marginal Zone Lymphoma to see if it works better and is safer than traditional chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Huai'an First People's Hospital (Academic / other)
• Drugs / interventions: Obinutuzumab, Orelabrutinib, chemotherapy
• Locations: 1 site (Huai'an, Jiangsu)
• Trial ID: NCT06566807 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective study aims to evaluate the efficacy and safety of a combination of Orelabrutinib and Obinutuzumab for patients with previously untreated Marginal Zone Lymphoma (MZL). The trial will involve administering six cycles of the O2 regimen, followed by a year of single-agent Orelabrutinib for patients who achieve a complete or partial response. MZL is a common type of B-cell non-Hodgkin lymphoma, and this study seeks to explore a chemotherapy-free treatment approach that may reduce safety risks associated with traditional regimens. The study is designed to provide valuable insights into effective treatment options for MZL patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed CD20-positive Marginal Zone Lymphoma.

Not a fit: Patients with MZL who have previously received treatment or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and effective option for patients with Marginal Zone Lymphoma.

How similar studies have performed: Other studies have shown promising results with BTK inhibitors in treating Marginal Zone Lymphoma, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Aged ≥18 years, gender not limited;
* Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
* MZL that has progressed, recurred, or is not suitable for local treatment after previous local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, and hepatitis C treatment);
* ECOG 0-2;
* Indication for treatment as judged by the investigator (symptomatic, with cytopenia, at risk of end-organ damage, bulky disease, persistent progression, or patient\'s desire for treatment);
* Major organ function meets the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 ULN, AST or ALT ≤2 ULN; serum creatinine ≤1.5 ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 ULN.
* Expected survival time ≥3 months;
* Voluntarily sign a written informed consent form before the trial screening.

Exclusion Criteria:

* Currently or previously diagnosed with other malignant tumors, unless curative treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years;
* Lymphoma involving the central nervous system or transformation to a higher grade;
* Active bleeding within 2 months prior to screening, or currently taking anticoagulant medications, or the investigator considers there to be a definite bleeding tendency;
* Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening;
* Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases;
* Any mental or cognitive disorder that may limit the understanding, execution, and compliance with the informed consent form and the study;
* Pregnant or lactating women and women of childbearing age who are unwilling to take contraceptive measures;
* Need to continuously take drugs with moderate to severe inhibitory or strong inductive effects on cytochrome P450 CYP3A;
* Other conditions that the investigator considers unsuitable for participating in this trial.

Where this trial is running

Huai'an, Jiangsu

• The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital# — Huai'an, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Chunling Wang

Conditions Marginal Zone Lymphoma; orelabrutinib